VS3 System Receives FDA Breakthrough Device Designation to Treat Debilitating Pulsatile Tinnitus

• The FDA granted Breakthrough Device designation to the investigational VS3 system.
• The designation was based on evidence indicating the system has the potential to resolve pulsatile tinnitus associated with venous sinus stenosis.
• The self-expanding device is designed to conform to the venous sinus and treat intrinsic and extrinsic stenoses.

September 29, 2026-VS3 Medical, Inc., a developer of neurovascular implants, announced that the company's VS3 system has been granted FDA Breakthrough Device designation. The company advised that the designation is based on evidence demonstrating that the system has the potential to resolve debilitating pulsatile tinnitus caused by venous sinus stenosis.

According to the company, the investigational VS3 system was designed to specifically address the unique properties of the venous anatomy and stenoses. The self-expanding device is intended to conform to the venous sinus and provide sufficient radial force to open intrinsic and extrinsic stenoses. Its dedicated stent delivery system is designed to smoothly navigate the venous sinus anatomy and accurately position the stent upon deployment.

The company explained that pulsatile tinnitus may be a result of abnormal flow in the venous vasculature of the brain caused by venous sinus stenosis. Symptomatic venous sinus stenosis is characterized by narrowing of the brain's main drainage sinuses either from extrinsic compression or large arachnoid granulations present in the venous sinus near the ear, noted the press release.

The founder of VS3 Medical is Matthew Amans, MD, who is Professor of Radiology and Neurological Surgery at University of California, San Francisco, in San Francisco, California.

"We believe the FDA's recognition of pulsatile tinnitus as a debilitating condition is another positive step towards more timely diagnosis and appropriate treatment pathways for patients," commented Dr. Amans in the press release. "Advances in imaging have significantly improved our understanding of the intracranial venous anatomy, enabling the development of technologies like ours that are designed to specifically address the underlying anatomical causes of symptomatic venous sinus stenosis."